VAERS Reports U6521AB

VAERS 1653413

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6521AB

gering

Staat: NC
Alter: -
Geschlecht: U
Eingang: 29.08.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

patient was administered an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 21-Aug-2021 from a Pharmacist via Medical Information (Reference number- 00734255) and transmitted to Sanofi on 23-Aug-2021. This case involves a patient (unknown age and gender) who administered an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no adverse event (expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6521AB, expiry date 26-Jan-2021] via unknown route in unknown administration site for prophylactic vaccination. It was reported, "A patient was given an expired dose of Menactra". It was a case of actual medication error due to expired vaccine used (latency was on the same day). At the time of reporting, patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1653401

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6521AB

gering

Staat: IL
Alter: 17,0
Geschlecht: M
Eingang: 29.08.2021
Impfdatum: 14.08.2021
Beginn: 14.08.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

medical assistant provided expired MENACTRA vaccine to a patient/no AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a Physician via (Medical Information-00730396). This case involves a 17 years 3 months old male patient who was vaccinated with expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines were not provided. On 14-Aug-2021, the patient received 0.5 mL (total; standard) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AB and expiry date 26-Jan-2021) via an intramuscular route at the left deltoid for prophylactic vaccination. It was reported "HCP called back to provide AE information from previous call that he had to disconnect from. Doctor reports that medical assistant provided expired MENACTRA vaccine to a patient on 14Aug2021.Doctor also asked about the most common side effects that may occur with an expired dose of MENACTRA but was unable to hold for a MIS transfer. Caller was advised on previous call that vaccine was not valid. MA got the expiration date confused and mixed up the year with the date 26-Jan-21. She thought it expired in 2026". It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. Event outcome was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1349698

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6521AB

gering

Staat: -
Alter: -
Geschlecht: U
Eingang: 26.05.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Medication error No adverse event Wrong product administered

Symptomtext

patient got Menactra when they were supposed to get meningococcal B, no AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (inquiry reference number 00598144). This case involves a patient of unknown age and gender patient who got MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6521AB and expiration date not reported) when was supposed to get MENINGOCOCCAL VACCINE B not produced by Sanofi Pasteur (lot number U6521AB and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date (wrong product administered). The patient's past medical history, medical treatment(s), vaccination(s), concomitant mediation(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered (same day latency). It was reported that registered pharmacist was calling to see if a Lot number provided matches the Menactra vaccine that had been given inappropriately. Checked her stock and the lot number did not match. This was given a few months back and the lots have changed. Caller said she was calling from overseas. She was asking to confirm if a certain lot (given here) was Menactra. Caller also stated that a physician noticed in a patient chart recently that this patient got Menactra when they were supposed to get meningococcal B. Caller also said that they were not sure if maybe the nurse who documented this typed in Menactra instead of meningococcal B by mistake. Caller said the lot number documented was U6521AB. Caller does not have any details on patient. She said this happened months ago. They are not even sure if this was an error. If Sanofi can confirm that the lot is not Menactra then it was probably typed wrong by nurse. No AE (adverse event) template done as caller does not have any details. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1030232

SANOFI PASTEUR · MENINGOCOCCAL CONJUGATE (MENACTRA) · Charge U6521AB

gering

Staat: IL
Alter: 71,0
Geschlecht: M
Eingang: 15.02.2021
Impfdatum: 03.02.2021
Beginn: 03.02.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

71 year old male patient received an expired dose of Menactra, no AE; 71 year old male patient received an dose of Menactra, no AE; Initial information received on 03-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 71 year old male patient who was vaccinated with an expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered and Product administered to patient of inappropriate age). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 03-Feb-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AB and expiry date: 26-Jan-2021) (frequency once) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration (latency on same day). It was also reported that description pharmacy operations manager said that they had a vial of MENACTRA that expired on 26-Jan-2021. She says that they accidentally administered the vaccine to a patient today. Caller would like to find out if the vaccine would need to be re-administered to the patient. Additional Description of event adverse events a pharmacy operations manager reporting on behalf of a consumer that received an expired dose of Menactra, on 03-Feb-2021. Reporter relationship: (HCP) health care professional, Product used: used still using product: no At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -